Mindfulness and Neural Cardiovascular Control in Humans

Michigan Technological University

Status: Completed

Conditions: Elevated Blood Pressure

Treatments: Behavioral: Stress Management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03626363

1R15HL140596-01 (U.S. NIH Grant/Contract)

M1690

Details and patient eligibility

About

This study evaluates the impact of mindfulness-based stress reduction (MBSR) on sympathetic nerve activity and arterial stiffness. The investigator's central hypothesis is that MBSR will reduce sympathetic activity and arterial stiffness.

Full description

This study will recruit male and female subjects with elevated blood pressure who will participate in a randomized, active control study to examine the impact of mindfulness-based stress reduction (MBSR) on blood pressure, muscle sympathetic nerve activity and arterial stiffness. The study will utilize established techniques for assessing blood pressure patterns (24-hour ambulatory monitoring), peripheral sympathetic activity (microneurography) and vascular stiffness (applanation tonometry) in humans. This study includes a stress management education class for the active control.

Enrollment: 52 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Seated systolic blood pressure >119 mmHg and/or diastolic blood pressure >79 mmHg
• Body mass index <30 kg/m2

Exclusion criteria

• Smokers
• Diabetes
• Pregnant women
• History of autonomic dysfunction
• Cardiovascular medication

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

52 participants in 2 patient groups

Mindfulness-Based Stress Reduction

Experimental group

Description:

An 8-week program specifically designed to improve mindfulness and to reduce stress.

Treatment:

Behavioral: Stress Management

Stress Management Education

Active Comparator group

Description:

An 8-week program specifically designed to provide education about stress responses in humans, and as an active control for Mindfulness-Based Stress Reduction studies.

Treatment:

Behavioral: Stress Management